There has been no report on whether the patients with colorectal cancer who are also inactive Hepatitis B Carriers should receive Prophylactic Use or preemptive Use of an Anti-viral Drug Entecavir. This open, randomized controlled clinical trial aims to compare the impact of the prophylactic use or preemptive use of an anti-viral drug Entecavir on the outcomes of patients with colorectal cancer who are also inactive hepatitis B carriers during chemotherapy and the subsequent follow-ups.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
50
anti hepatitis B virus
Sun Yat-sen University Cancer Center
Guangzhou, Guangdong, China
RECRUITINGIncidence of hepatitis B virus associated hepatitis
Hepatitis is defined as a 3-fold or greater increase in the serum ALT level that exceeded the reference range (\>58U/L) or an absolute increase in the level of ALT of greater than 100 U/L compared with the baseline level
Time frame: through study completion, an average of 1 year
Incidence of hepatitis B virus reactivation
Reactivation of HBV is defined as a 10-fold or greater increase in the HBV DNA level or an absolute increase of 10\^5 copies/mL or greater compared with the baseline value.
Time frame: through study completion, an average of 1 year
Interruption of chemotherapy due to hepatitis
Chemotherapy disruption is defined as either premature termination or a delay of at least 7 days between chemotherapy cycles.
Time frame: through study completion, an average of 1 year
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